MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES EPIX LAPAROSCOPIC GRASPER; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number	C4130
Medical Device Problem Codes	Material Frayed (1262); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: appendix event description: the grasper repeatedly get caught on the bowel during surgery and thus cause injuries.Additional information received from company rep.Via email on 04feb2025: the grasper got caught at the proximal end of the padding.No injury.The intestine has become stuck at the proximal end of the padding (several times during surgery).Intervention: intestine shaken off the grasping patient status: no injury.Patient is good.
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as no catching was observed on the grasper pads when the unit was used to grasp porcine bowel tissue.The event unit met current specifications and there were no visible non-conformances.It is possible that there are unknown clinical factors that could have contributed to the customer experience, including but not limited to various use cases by the surgeon or the patient state.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.The probability and criticality of the harm resulting from this event have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: appendix.Event description: the grasper repeatedly get caught on the bowel during surgery and thus cause injuries.Additional information received from company rep.Via email on 04feb25: the grasper got caught at the proximal end of the padding.No injury.The intestine has become stuck at the proximal end of the padding (several times during surgery).Intervention: intestine shaken off the grasping.Patient status: no injury.Patient is good.

• Brand Name: EPIX LAPAROSCOPIC GRASPER
• Common Device Name: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21337184
• Report Number: 2027111-2025-00351
• Device Sequence Number: 15609403
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C4130
• Device Catalogue Number: 101476261
• Device Lot Number: 1522829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAP BIPOLAR.; LAP OVERHOLT.; SCISSORS.
• Patient Sex: Unknown